Although self testing kits provide reliable results, they are not meant to replace traditional healthcare pathways, but can help prompt patients to discuss their concerns with their doctor sooner than they might have. Used in an appropriate way, self testing kits can foster equality, accessibility and have the potential to reduce the burden on primary care by empowering patients to take more control over their health.
How we support our SELFCHECK customers
We believe that the provision of professional customer care is an essential component for any supplier of self-test kits. With over 25 years experience in the development of laboratory and point of care medical diagnostics, our team of scientific and regulatory experts are on hand to help our customers with any questions they may have about their test. It is, however, a UK and EU regulatory requirement for medical device manufacturers to advise self-test users to speak with their doctor or pharmacist before making any changes to their medication or lifestyle.
Regulation of the manufacturers
The majority of manufacturers of self testing kits are medical device and pharmaceutical companies that develop and produce diagnostics for hospital laboratory use. These companies are strictly regulated with annual independent on-site inspections and are required to have certification to international standards for the manufacture of medical devices (ISO13485:2016).
The components used in the SELFCHECK range of self testing kits are also themselves manufactured by certified medical device companies. For example, the single use lancets used in our finger-prick blood tests are exactly the same as those routinely used in NHS clinics. The SELFCHECK range is assembled at our ISO13485:2016 certified laboratories in St Asaph and distributed predominantly through major pharmaceutical wholesalers and retailers.
Regulation of self testing kits
Self test kits are medical devices, registered with MHRA and tightly regulated in the UK in the same way as hospital laboratory dagnostics. Prior to certification and use, all self testing kits have to be independently evaluated by a Notified Body such as mdc, TUV or BSi. This is to ensure that the manufacturing processes, intended use, reliability, claims and limitations made on the packaging and instructions for use by the manufacturer are appropriate. Manufacturers of self testing kits also have to provide evidence to the Notified Bodies that the tests are easy to use and interpret by laypersons.
What do the tests detect?
Self testing kits use the same chemistry and biomarkers used in hospital laboratory tests. For example, immunological tests for the detection of biomarkers such as tissue transglutaminase IgA antibodies (tTG IgA) for the diagnosis of coeliac disease or blood glucose levels for the diagnosis of diabetes. Many self tests utilise lateral flow technology that has been used for decades in pregnancy tests and more recently FIT bowel screening tests, and for the rapid diagnosis of COVID infections.
Self testing kits have already demonstrated that they can make an important contribution to healthcare in the UK and we welcome opportunities to discuss with clinicians and stakeholders further innovation in this sector.